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Presented by Optum Rx: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim and Katherine Ellen Foley | | | | | | | 
The FDA granted the Alzheimer's drug Leqembi accelerated approval in January, and today it will be considered for traditional approval. | Eisai via AP | ADVISERS CONSIDER LEQEMBI’S FULL APPROVAL — Today, the FDA’s expert advisers on neurological drugs will discuss the application for traditional approval for Leqembi, the second treatment for Alzheimer’s disease to reach the market. Briefing documents published ahead of the meeting indicate the FDA staff have serious questions about Leqembi’s side effects, brain swelling and bleeding, which state they occurred in more than 13 percent of patients in the drug’s Phase III clinical trial. However, agency scientists note that the companies’ Phase III trial met their primary and secondary endpoints of slowing the progression of cognitive decline and said that safety concerns were raised when the FDA granted accelerated approval of the drug. The agency gave Leqembi accelerated approval in January based on data from Phase II trials that showed the antibody successfully removed a protein from patients’ brains that is believed to be linked to the disease’s cognitive declines. CMS said it would only cover the drug for patients enrolled in a randomized trial — but none have enrolled since the approval. Leqembi’s makers, Eisai and Biogen, published data from a completed Phase III trial of the drug in December, before the FDA’s initial decision. If the FDA grants Leqembi traditional approval, Medicare would cover the drug for those enrolled in a patient registry. Earlier this month, CMS said it would create an “easy-to-use” national portal that would be ready to use by July 6, when the agency is set to make an approval decision. Patients’ access to the Alzheimer's drug — which would be the first one to receive traditional approval in more than two decades — will depend on whether health care providers are willing to use the portal. Some doctors have said registry participation is a cumbersome step. Meanwhile, the out-of-pocket cost for Leqembi is more than $26,000 annually, which has not escaped the notice of Sen. Bernie Sanders (I-Vt.). He is pushing for the manufacturers to reduce the price ahead of any rollout. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. If you’re in the Beltway area like your co-authors, we hope you’ve been able to limit your time outside to avoid the smoky air. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with Carmen Paun about the skepticism that HHS Secretary Xavier Becerras expressed about future funding for Covid vaccines at this week’s POLITICO Health Care Summit.
| | | | | A message from Optum Rx: Community and independent pharmacies play a vital role in people’s health care, especially for people living in rural and underserved communities. That’s why Optum Rx is proud to partner with more than 26,000 community pharmacists to deliver care, improve the pharmacy experience and help make prescription drugs more affordable. Learn more. | | | | | | | 
A panel of outside experts has recommended that the FDA approve a new treatment to help protect infants against RSV. | Alain Jocard/AFP via Getty Images | ADVISERS ENDORSE RSV ANTIBODY FOR INFANTS — The FDA’s independent experts voted 21-0 on Thursday to recommend the agency approve a new treatment intended to offer infants protection against respiratory syncytial virus during their first year of life. They also voted 19-2 that the FDA approve a second dose of the same treatment for children under 2 years old as additional protection ahead of their second RSV season if they are at risk of severe disease. Nirsevimab, a monoclonal antibody from AstraZeneca and Sanofi, is not a vaccine because it doesn’t cause infants to produce their own immune response. But in late-stage trials, it reduced doctors’ visits and hospitalizations in babies born at 39 weeks and as early as 29 weeks gestation compared to a placebo, with no serious safety concerns. It was not studied in babies born earlier. “[This] really moves the field forward, especially considering … how severe RSV is and the toll it's taken on health systems,” said Nimish Patel, a professor of clinical pharmacy at the University of California, San Diego, who voted to recommend the antibody’s approval. Advisers who voted against recommending nirsevimab’s approval for at-risk children ahead of their second RSV season want to see more data. “It’s a bit of a weak ‘no,’” said Sally Huntsberger, a biostatistician at the National Institute of Allergy and Infectious Diseases, who said she hoped her negative vote would lead to further study. FDA ISSUES DRUG SHORTAGE REPORT — The agency released its annual report on drug shortages on Wednesday, providing new details on pharmaceutical supply-chain disruptions in 2022. “FDA has seen manufacturers in the United States and abroad continue to experience quality issues and struggle with capacity constraints,” the report states. Demand for Covid-19, respiratory syncytial virus and seasonal influenza medications “made it harder for FDA and manufacturers to avoid drug shortages.”
| | | | A message from Optum Rx:   | | | | | APPROPS MARKUPS TO RESUME — The House will pick back up with markups of fiscal 2024 spending bills next week after House Appropriations Chair Kay Granger (R-Texas) postponed them late last month in what she described as an effort to give Speaker Kevin McCarthy maximum leverage as he neared a debt ceiling agreement with President Joe Biden, POLITICO’s Caitlin Emma reports. The full spending panel is expected to take up at least a few of the bills — such as a package that funds the FDA — which has been advanced by a subcommittee, according to a House GOP aide granted anonymity to discuss the committee’s plans. CHOPPY WATERS FOR SUPPLY-CHAIN POWERS — The House Energy and Commerce Health Subcommittee will meet Tuesday to discuss a draft bill reauthorizing the Pandemic and All-Hazards Preparedness Act, but partisan divides and lingering tensions from Covid-19 legislative battles endanger several bills Democrats say are needed to prevent future supply-chain disruptions, which were widespread at the start of the pandemic. Legislation to shore up the pharmaceutical and medical device supply chain that Democrats asked to be included in the reauthorization won’t be reviewed at the Tuesday hearing, according to E&C ranking member Frank Pallone (D-N.J.). “These policies include improved mandatory reporting of drug and medical device shortages, increased transparency in drug and active pharmaceutical ingredient manufacturing, new tools to support extended drug shelf life during shortages like the ongoing cancer drug supply shortages, and recall authority to ensure dangerous products can be removed from the market quickly,” Pallone said. Republicans argue the excluded measures should instead be considered as part of a “more comprehensive reform” of public health agencies, including the CDC and the NIH, and their inclusion could jeopardize reauthorization of the law, first signed into law by President George W. Bush in 2006.
| | | | GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGISTER HERE. | | | | | | | | | MERCK LAWSUIT ASSIGNED TO JUDGE — Merck’s lawsuit filed this week to block Medicare drug price negotiations, a key element of last year’s Inflation Reduction Act, was assigned to Judge Randolph Daniel Moss. The U.S. District Court for the District of Columbia judge was nominated by former President Barack Obama and confirmed by the Senate by a 54-45 vote in 2014.
| | | FTC EXPANDS PBM PROBE — On Thursday, the FTC issued a compulsory order to group purchasing organization Emisar Pharma Services, directing it to provide business records and other information as part of the agency’s ongoing investigation of pharmacy benefit managers. Similar orders were previously issued to the six largest PBMs, and GPOs Zinc Health Services and Ascent Health Services.
| | | JHA DEPARTING — Ashish Jha is stepping down from his role as White House Covid-19 response coordinator on June 15 to return to his job as dean of the Brown University School of Public Health, the White House confirmed Thursday.
| | The FDA named Iilun Murphy as permanent director of the Center for Drug Evaluation and Research’s Office of Generic Drugs effective June 18. Susan Rosencrance, who served in the role in an acting capacity, will become acting principal deputy director of the office until she returns to her permanent job at the end of August as director of the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality.
| | A message from Optum Rx: Optum Rx, a pharmacy care services company, is taking action to support community and independent pharmacies and the important role they play on the front lines of care to drive better health outcomes and identify unmet needs for the patients they serve.
• Pharmacy Solutions: Reducing administrative burdens to improve outcomes and ensure pharmacists are paid fairly.
• Predictability: Providing greater predictability of reimbursements for prescription drugs and improved analytics.
• Enhanced Reimbursement: Creating increased revenue opportunities for community pharmacies that help expand access to care, connect patients to services that address unmet needs such as food, nutrition, transportation, housing, and baby supplies, and improve medication adherence and health outcomes for their underserved and rural patients.
Community and independent pharmacies play a vital role in health care and supporting their expanded role as health care providers is more important than ever. Learn more. | | | | | FDA Commissioner Robert Califf told pharmaceutical executives at BIO 2023 that it makes sense for government health insurers like Medicare to pay less for drugs that have not yet received traditional approval, the Boston Globe’s Robert Weisman reports. The Biden administration released a strategy on Thursday for combating sexually transmitted infections — which have climbed to record rates the past few years, POLITICO’s Alice Miranda Ollstein reports. Former FDA Commissioner Scott Gottlieb and his former chief of staff Lauren Silvis write in JAMA Health Forum this week that Congress may need to give the FDA new authorities so it can effectively regulate artificial intelligence.
| | The FDA released draft guidance outlining good clinical practice recommendations intended to make clinical trials more efficient and safer for participants.
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